MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 1.85MM X 16 MM FRTR,CRNA; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Catalog Number	A-CRN-G1
Medical Device Problem Codes	Fracture (1260); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The actual device was returned for evaluation.Quality engineering evaluated the cutter device and the reported condition that the burr device was unable to be detached from the craniotome device was confirmed.An assessment was performed and it was determined that the cutter device broke while trying to remove it from the attachment device.It was reported that the cutting device was received stuck in the craniotome attachment device and the cutter was fully corroded, and debris was all over the cutting tool.The assignable root cause was determined to be traced to user, which is user error.A review of the device history was performed and no non-conformances were detected related to the reported condition.Udi ¿ (b)(4).
Event or Problem Description
It was reported from (b)(6) that during service and evaluation, it was observed that the cutter device broke while trying to remove it from the attachment device.It was reported that the cutting device was received stuck in the craniotome attachment device.It was reported that the cutter was fully corroded, and debris was all over the cutting tool.It was reported in the service order that the craniotome had bearing damage and the burr device was unable to be detached.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 1.85MM X 16 MM FRTR,CRNA
• Common Device Name: MOTOR, DRILL, ELECTRIC - CUTTING BURR
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11003905
• Report Number: 1045834-2020-02100
• Device Sequence Number: 13670350
• Product Code: HBC
• UDI-Device Identifier: 00845384012603
• UDI-Public: 845384012603
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K113476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2024
• Device Catalogue Number: A-CRN-G1
• Device Lot Number: N033135142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1